510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K002912Substantially Equivalent

Vaginal Port, Non-Sterile / 600065, Vaginal Port, Sterile / 600073

Sterinc, Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002912 is the FDA 510(k) clearance record for VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073, a class II device, cleared for Sterinc on under FDA product code HIB (Speculum, Vaginal, Nonmetal). FDA records list one 510(k) clearance for Sterinc. As of , FDA records show no recalls naming K002912.

Clearance record

Decision date
Received
(156 days to decision)
Product code
HIB Speculum, Vaginal, Nonmetal
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Sterinc 3520 W. Warner Ave., Santa Ana CA
510(k) summary
Summary
Third party review
No

Clearances, product code HIB

Trailing 12 months
1 clearance under product code HIB in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HIB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260